| Considering whether less haste in the short-term might actually improve speed-to-market, Mike Macnamee of LCG Bioscience urges the incorporation of patient studies into early stage clinical research
Although it is clear that there are many benefits of using patients in the early stages of clinical trials, it is also evident from recent discussions between sponsors and researchers that the use of patients before Phase II is still very limited. One of the reasons for this is that patient studies can be more timeconsuming to conduct, and this is an industry driven by speed. Additionally, while volunteer trials are well understood and the outcomes easily interpreted, patient trials are a new departure and generate a wealth of data that can create uncertainty in interpretation for both sponsor and regulatory authorities. STOPPING EARLY STAGE TRIALS
One of the most effective ways in which pharmaceutical companies can hope to improve the efficiency of their development programmes is to terminate any project that is destined to fail as soon as possible. However, it is difficult in traditional drug development to distinguish winners from losers. And although it is late stage failures that cause the most angst for drug developers, there could be just as many promising compounds with useful indications that are dropped at the early stages because there is insufficient evidence of biological activity to justify the risk versus benefit ratio of their progression through the regulatory process. |
